AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

FDA device recall Z-0567-2024 · posted 2023-12-15 · Open, Classified

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

Action taken

On 11/06/23, Recall and Field Safety Alert notices were sent to customers. The recall notices asked customers to do the following: 1) Complete and return business reply form by email to RSRecall@stryker.com 2) Firm recommends continued use. Follow the OI recommendations for daily inspection and testing according to the checklist provided in the Operating Instructions. a. The checklist includes disconnecting the defibrillator from the power adapter, turning the device on, and confirming that two batteries are installed and charged. Then, the defibrillator should be reconnected to the power adapter and users should confirm that the battery charging LED on the defibrillator is illuminated or flashing. b. If an ACPA is experiencing this failure mode, this will present to the user as the Aux Power Indicator on the LP15 flashing instead of solidly illuminating and the green LED strip on the ACPA flashing instead of solidly illuminating: 3) Please notify impacted customers that were shipped or may have been shipped this affected product by sharing this recall notification letter; Email Stryker at RSRecall@stryker.com with a list of customers who received/may have received this product and we can work with you on notifications to impacted customers. If you have any questions or feel that your ACPA may be experiencing issues, please contact Customer Service at 1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday - Friday or by email at medtechsup@stryker.com

Root cause

Component change control

Status

Open, Classified

Product code

MKJ

Quantity affected

18,732

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA

Date initiated

2023-11-06

Date posted

2023-12-15

Location

Redmond, WA